MDCG 2026-5 clarifies that only the manufacturer can assign UDIs to devices placed on the EU market, even where distributors market devices under their own brand.

The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.

The MDCG has published MDCG 2024-10, providing guidance on the clinical evaluation of orphan medical devices, including recommendations on clinical evidence generation, study design, post-market clinical follow-up and benefit-risk assessment under the MDR.

The MDCG has published an appendix to MDCG 2021-5 clarifying the transition from the 'EC REP' to the 'EU REP'symbol under EN ISO 15223-1, including a five-year transition period for medical device and IVD manufacturers.

The MDCG has published MDCG 2026-4, providing clarification on the management of Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) documents in EUDAMED following the mandatory use of the platform’s first modules.

MDCG publishes Revision 2 of EMDN guidance, clarifying code assignment, updates, and EUDAMED requirements under MDR and IVDR.

New EU Borderline & Classification Manual v5 (April 2026) published. Key MDR/IVDR qualification and classification examples for manufacturers.

MDCG updates medical device classification guidance under EU MDR. Key changes manufacturers must review for compliance and documentation.

MDCG 2025-8 Rev.1 provides guidance on Master UDI-DI implementation for spectacle frames, lenses, and reading spectacles under EU MDR. Learn key requirements, timelines, and assignment rules.

Discover how MDCG 2025-9 opens a new regulatory pathway for breakthrough medical devices and IVDs under MDR and IVDR. Learn what manufacturers need to know to benefit from early designation, lifecycle evidence flexibility, and post-market strategies.

MDCG has published Revision 4 of MDCG 2020-16, updating the classification of in vitro diagnostic medical devices (IVDs) in accordance with IVDR Regulation (EU) 2017/746. Among the main changes is the reclassification of SARS-CoV-2 tests. In addition, adjustments have been made to the classification of blood, tissue and organ screening tests, as well as clarifications for complementary diagnostics and self-tests.

The MDCG scientific opinion on SARS-CoV-2 assesses the impact on the classification of IVD devices in accordance with Regulation (EU) 2017/746. The reassessment considers the evolution of the pandemic and the current epidemiological scenario, analysing transmissibility and life risk in the general population and in risk groups. This opinion is crucial for the medical device industry, especially to ensure regulatory compliance.

MDCG 2021-12 Rev.1 FAQ provides a detailed explanation of the European Medical Device Nomenclature (EMDN), which is an essential resource for ensuring the compliance of medical devices and IVDs in the context of the European Union's MDR and IVDR regulations. With the January 2025 revision, this document guides manufacturers on how to correctly assign EMDN codes to their devices in EUDAMED. In addition, it clarifies aspects of the hierarchical structure of the nomenclature, the use of alphanumeric codes, and the annual nomenclature update process.